Reported Mar 18, 2015 · Terminated
EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx ONLY,…
Microport Orthopedics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Microport Orthopedics INC. · 5677 Airline Rd · Arlington, TN · 38002-9501
Is this the product you have?
- EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx ONLY, MicroPort Orthopedics, Inc. Knee prosthesis component.
- Lot codes and dates
- Lot Numbers
15601401560140156889715601401570896
- Lot Numbers
- Amount recalled
- 17 units
Where it was sold
Why it was recalled
Some units of the EVOLUTION Tibial Base was affected by a casting tool issue which caused varying retaining wall thickness and keel offset in the finished product.
This product could cause temporary or reversible health problems — stop using it.
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